本發明係提供一種椎體骨水泥注射方法，尤其是指一種以演算法控制壓力值來引導骨水泥之注射方法。The present invention provides a method for vertebral bone cement injection, and more particularly, a method for guiding bone cement injection by controlling pressure value with an algorithm.
自二十世紀末期開始利用骨水泥治療脊椎血管瘤疼痛的病人開始，骨填充物對於骨科治療之運用的重要性即日益遽增。尤其是將骨填充物運用於脊椎骨支撐及椎體成型以避免脊椎神經遭受壓迫的治療方法，更是能取代傳統神經減壓手術為主或合併傳統脊椎固定手術解決神經壓迫的方式。椎體成型的微創手術係經由經皮穿刺的方式於椎體內施行，其是將人工骨水泥(Poly-methylmethacrylate, PMMA)或其他骨填充材料置入受損之椎體內，以增強椎體強度和脊椎之穩定性，並減少病患因脊椎椎體受損而產生的慢性疼痛。為了將骨填充物順利置入受損之椎體內，骨填充物之植入器具即顯得相當的重要，其注入速率之穩定度、施力、便利性以及與其他器械搭配的適應度，皆與操作難易度有密不可分的關係，也影響著手術的成效。Since the late 20th century, when bone cement was first used to treat patients with spinal hemangioma pain, the importance of bone fillers in orthopedic treatment has increased dramatically. In particular, the use of bone fillers in spinal support and vertebroplasty to prevent spinal nerve compression can replace traditional nerve decompression surgery or combine it with traditional spinal fixation surgery to solve nerve compression. The minimally invasive vertebroplasty procedure is performed percutaneously in the vertebral body. It is to place artificial bone cement (Poly-methylmethacrylate, PMMA) or other bone filling materials into the damaged vertebral body to enhance the vertebral strength and stability of the spine, and reduce the patient's chronic pain caused by vertebral damage. In order to successfully place the bone filler into the damaged vertebral body, the bone filler implantation device is very important. The stability of the injection rate, force, convenience, and compatibility with other instruments are closely related to the difficulty of operation and also affect the effectiveness of the operation.
現有技術下的骨水泥注入裝置多數係以針筒或特殊設計之注射器，將骨水泥注入目標骨椎體中。然而，因椎體骨質疏鬆、破損，或因操作者提供過大的注射壓力而造成骨水泥滲漏至椎體外的情況，產生安全疑慮。Most bone cement injection devices in the prior art use a syringe or a specially designed injector to inject bone cement into the target vertebral body. However, due to osteoporosis or damage of the vertebral body, or due to excessive injection pressure provided by the operator, bone cement may leak out of the vertebral body, causing safety concerns.
在骨水泥注射面臨的最大困難是骨水泥於注射過程中所造成的溢流現象，於現有技術下，已有JINJ-5173；No. of Page6之「Decompressed percutaneous vertebroplasty：A secured bone cement delivery procedure for vertebral augmentation in osteoporotic compression fractures」之學術論文提供一種在進行注射骨水泥時，同時對椎體的對側施加恆定連續抽吸壓力的骨水泥注射方法，以降低骨水泥注射過程的滲漏機率，可做為更安全有效的骨水泥注射方法之選擇。然而，前述之學術論文中所提出之注射方法，僅能就骨水泥注射過程中可能發生的堵塞或溢流情形，憑據醫師經驗進行注射情況的控制。例如，當骨水泥逐漸填滿脊椎椎體內部時，持續灌注骨水泥可能造成其滲漏到腔體外或靜脈內的風險，造成骨水泥注射過程中之滲漏，進而讓病患產生神經受到壓迫或肺栓塞等的併發症。The biggest difficulty in bone cement injection is the overflow of bone cement during the injection process. In the existing technology, there is an academic paper JINJ-5173; No. of Page6 "Decompressed percutaneous vertebroplasty: A secured bone cement delivery procedure for vertebral augmentation in osteoporotic compression fractures" that provides a bone cement injection method that applies a constant continuous suction pressure to the opposite side of the vertebral body while injecting bone cement to reduce the probability of leakage during the bone cement injection process. It can be used as a safer and more effective bone cement injection method. However, the injection method proposed in the aforementioned academic paper can only control the injection situation based on the doctor's experience in the case of blockage or overflow that may occur during the bone cement injection process. For example, when bone cement gradually fills the inside of the vertebral body, continued perfusion of bone cement may cause the risk of leakage outside the cavity or into the vein, causing leakage during the bone cement injection process, and then causing complications such as nerve compression or pulmonary embolism in patients.
因此，如何提供一種安全有效的骨水泥注射方法，可以克服骨水泥注射過程中可能產生的溢流現象，則成了相關產業亟需克服的課題。Therefore, how to provide a safe and effective bone cement injection method that can overcome the overflow phenomenon that may occur during the bone cement injection process has become an issue that the relevant industry needs to overcome urgently.
本發明之主要目的，係提供一種演算法控制壓力引導之骨水泥注射方法，透過此一方法，可即時評估病患脊椎椎體骨水泥灌注狀態，及時調整注射參數或模式或停止骨水泥注射。The main purpose of the present invention is to provide an algorithm-controlled pressure-guided bone cement injection method, through which the bone cement perfusion status of the patient's vertebral body can be evaluated in real time, and the injection parameters or mode can be adjusted or the bone cement injection can be stopped in time.
本發明之又一目的，係提供一種演算法控制壓力引導之骨水泥注射方法，可即時針對該病患脊椎椎體之骨水泥注入飽和程度，作為注射條件的參考或依據。Another object of the present invention is to provide an algorithm-controlled pressure-guided bone cement injection method that can instantly measure the saturation level of bone cement injection in the patient's spinal vertebrae as a reference or basis for injection conditions.
本發明之又一目的，係提供一種演算法控制壓力引導之骨水泥注射方法，可透過壓力系統內嵌入之演算法計算輸出壓力值，將骨水泥灌注至脊椎椎體內。Another object of the present invention is to provide an algorithm-controlled pressure-guided bone cement injection method, which can inject bone cement into the spinal vertebral body by calculating the output pressure value through an algorithm embedded in the pressure system.
本發明之又一目的，係提供一種演算法控制壓力引導之骨水泥注射方法，可透過感測裝置測量脊椎椎體內壓力變化，計算椎體內骨水泥灌注之飽和度做為調整注射條件的參考或依據。Another object of the present invention is to provide an algorithm-controlled pressure-guided bone cement injection method, which can measure the pressure changes in the vertebral body through a sensing device and calculate the saturation of bone cement perfusion in the vertebral body as a reference or basis for adjusting the injection conditions.
本發明之又一目的，係提供一種演算法控制壓力引導之骨水泥注射方法，透過此一注射系統，減少脊椎骨水泥灌注手術中發生的溢流現象。Another object of the present invention is to provide an algorithm-controlled pressure-guided bone cement injection method, through which the overflow phenomenon occurring during spinal cement perfusion surgery can be reduced.
為了達到上述之目的，本發明揭示一種演算法控制壓力引導骨水泥注射之方法，其包含如下步驟：設置初始壓力輸出值；感測至少一環境參數；依據環境參數計算脊椎椎體內壓力變化速率；判斷壓力變化速率是否小於壓力變化閥值；計算脊椎椎體內骨水泥飽和程度；決定加大壓力值或是停止骨水泥灌注裝置運作；當提高壓力輸出值部分的骨水泥會被抽出脊椎椎體外，只剩下些許部分骨水泥會以層流的模式留在椎體內壁；隨著操作時間的進程，骨水泥將會以漸層的方式充填進椎體內。In order to achieve the above-mentioned purpose, the present invention discloses a method for algorithm-controlled pressure-guided bone cement injection, which includes the following steps: setting an initial pressure output value; sensing at least one environmental parameter; calculating the pressure change rate in the spinal vertebra according to the environmental parameter; judging whether the pressure change rate is less than the pressure change valve value; calculating the saturation degree of bone cement in the spinal vertebra; deciding to increase the pressure value or stop the operation of the bone cement perfusion device; when the pressure output value is increased, part of the bone cement will be drawn out of the spinal vertebra, leaving only a small part of the bone cement in the laminar flow mode. The bone cement will be filled into the vertebra in a gradual manner as the operation time progresses.
為了達到上述之目的，本發明同時提供一種演算法控制壓力引導骨水泥注射之裝置，其包含：一壓力單元、一推動單元、一控制單元及一感測單元，其中該壓力單元用於提供一抽吸壓力；該推動元件用以推動一骨水泥遞送至脊椎椎體內；該感測元件用以感測至少一環境參數後，將該至少一環境參數傳遞至該控制單元中，其中控制單元包含一演算法模組，該演算法模組可以根據運算結果對壓力單元進行調節。In order to achieve the above-mentioned purpose, the present invention also provides an algorithm-controlled pressure-guided bone cement injection device, which includes: a pressure unit, a pushing unit, a control unit and a sensing unit, wherein the pressure unit is used to provide a suction pressure; the pushing element is used to push a bone cement into the spinal vertebral body; the sensing element is used to sense at least one environmental parameter and transmit the at least one environmental parameter to the control unit, wherein the control unit includes an algorithm module, and the algorithm module can adjust the pressure unit according to the calculation result.
於本發明之一實施例中，其亦揭露該至少一環境參數係為壓力導入裝置內之壓力值、壓力單元內之壓力值、目標部位內之壓力值。In one embodiment of the present invention, it is also disclosed that the at least one environmental parameter is the pressure value in the pressure introduction device, the pressure value in the pressure unit, and the pressure value in the target site.
為使貴審查委員對本發明之特徵及所達成之功效有更進一步之瞭解與認識，謹配合詳細之說明並佐以較佳之實施例，詳加說明如後：在本發明中，針對現有技術下的壓力骨水泥注射裝置無法得知脊椎椎體內部骨水泥填充情況進行因應，造成骨水泥滲漏影響病患安全，提供一種新穎的演算法控制壓力引導骨水泥注射之方法，該方法可即時的計算出病患脊椎椎體之骨水泥灌注狀況，並將訊號回饋給控制系統，以達到即時回饋控制之發明目的。In order to enable the review committee to have a further understanding and recognition of the characteristics and effects achieved by the present invention, a detailed description is provided with the aid of a preferred embodiment, and the details are as follows: In the present invention, in view of the fact that the pressure bone cement injection device under the existing technology cannot know the bone cement filling status inside the spinal vertebrae and respond accordingly, resulting in bone cement leakage affecting the safety of patients, a novel algorithm-controlled pressure-guided bone cement injection method is provided. The method can instantly calculate the bone cement perfusion status of the patient's spinal vertebrae and feed back the signal to the control system to achieve the invention purpose of real-time feedback control.
本發明所提供之演算法控制壓力引導骨水泥注射方法可在骨水泥注射的過程中，能藉由壓力的引導而均勻填補整個患部空間且降低骨水泥外漏風險。The algorithm-controlled pressure-guided bone cement injection method provided by the present invention can evenly fill the entire affected area space and reduce the risk of bone cement leakage by guiding pressure during the bone cement injection process.
因此，本發明提供一種新穎的演算法控制壓力引導骨水泥注射之方法，其包含感測至少一環境參數後將該至少一環境參數傳遞至該控制單元中，另一方面，其亦進一步透過演算法運算，以控制骨水泥於脊椎椎體內之注射情況。Therefore, the present invention provides a novel algorithm-controlled pressure-guided bone cement injection method, which includes sensing at least one environmental parameter and transmitting the at least one environmental parameter to the control unit. On the other hand, it further controls the injection of bone cement into the spinal vertebral body through algorithm operation.
基於上述方針，以下針對本發明所提供之演算法控制壓力引導骨水泥注射之方法與裝置所包含之元件、性質、其組合方式及其相互做動關係，進行進一步之說明：請參閱本發明之發明圖式第1圖，其係為本發明所提供之演算法控制壓力引導骨水泥注射之裝置，其中一較佳實施例之系統方塊圖，如圖所示，本發明所提供之該壓力引導骨水泥注射之裝置10係包含一壓力單元11、一推動單元12、一控制單元13及至少一感測單元14，該控制單元13包含一演算法模組131並且分別連接並控制該壓力單元11及該推動單元12，當該控制單元13自該至少一感測單元14獲得至少一感測參數時，該控制系統13之演算法模組131可計算出需要產生之壓力值並且對該壓力單元11進行骨水泥注射條件之控制。Based on the above principles, the following further describes the components, properties, combination methods and mutual action relationships of the method and device for algorithm-controlled pressure-guided bone cement injection provided by the present invention: Please refer to the invention drawing Figure 1 of the present invention, which is a system block diagram of a preferred embodiment of the device for algorithm-controlled pressure-guided bone cement injection provided by the present invention. As shown in the figure, the device 10 for pressure-guided bone cement injection provided by the present invention includes It comprises a pressure unit 11, a pushing unit 12, a control unit 13 and at least one sensing unit 14. The control unit 13 comprises an algorithm module 131 and is respectively connected to and controls the pressure unit 11 and the pushing unit 12. When the control unit 13 obtains at least one sensing parameter from the at least one sensing unit 14, the algorithm module 131 of the control system 13 can calculate the pressure value to be generated and control the bone cement injection conditions of the pressure unit 11.
本發明所提供的演算法控制壓力引導骨水泥注射之方法，當設置於該壓力單元11之任意位置上的該至少一感測單元14感測到至少一環境參數後，會將該至少一環境參數傳遞至該控制單元13中，接著，該控制單元13之演算法模組131會參考該至少一環境參數之內容進行運算，並與預先設定之理想數值進行比對，最後將比對出來的差異值作為基準，對該壓力單元11所提供之壓力強度進行控制，形成一個自我回饋的系統機制。透過自我回饋的系統機制，提供該演算法控制壓力引導骨水泥注射之裝置10相當便利的操作模式，相較於現況下單憑操作者的操作手感進行壓力強度的判斷及控制，更能提供較高的操作穩定性，以及更為精準且一致化的操作反應。The algorithm-controlled pressure-guided bone cement injection method provided by the present invention is such that when the at least one sensing unit 14 disposed at any position of the pressure unit 11 senses at least one environmental parameter, the at least one environmental parameter will be transmitted to the control unit 13. Then, the algorithm module 131 of the control unit 13 will refer to the content of the at least one environmental parameter for calculation and compare it with a preset ideal value. Finally, the difference value obtained by comparison is used as a benchmark to control the pressure intensity provided by the pressure unit 11, thereby forming a self-feedback system mechanism. Through the self-feedback system mechanism, the algorithm-controlled pressure-guided bone cement injection device 10 is provided with a very convenient operation mode. Compared with the current situation where the pressure intensity is judged and controlled solely based on the operator's operating feel, it can provide higher operation stability and more accurate and consistent operation response.
承續前段所言，本發明係提供一種設置至少一個感測單元14於該壓力單元11之任意位置上的該壓力引導骨水泥注射之裝置10，透過此一設計，使用者或者該控制單元13可以更為精準地從該至少一感測單元14的觀測結果中，了解該壓力單元11的操作情形、環境狀態以及壓力強度的即時變化等操作資訊，更甚者可以透過前述的資訊間接獲得該推動單元12的骨水泥遞送情形，並進行對應之壓力強度調整。相較於現有技術下其他類型的骨水泥注射器，包含同樣具有壓力引導但缺乏感測裝置的骨水泥注射系統，本發明所提供之壓力引導骨水泥注射方法可以更為精準的掌握到操作過程中，注射目標區域提供的壓力對於骨水泥注射的成效影響並進行對應之調整，使骨水泥注射的過程更為平順，且能避免因為不適當的施予壓力所造成的高滲漏風險。同時，壓力強度的感測及調整係屬於間接影響骨水泥注射的數值，可以在調動較大的調整值的狀況下，依舊獲得相當精細微小的注射條件變化。另一方面，當感測位置遠離骨水泥實際的注射端時，能使周遭的環境參數變動較為單純，獲得之測量值也較為準確，也因此可以獲得較為準確的回饋值以進行壓力強度的調整，提高注射系統的操作方便度。Continuing from the previous paragraph, the present invention provides a pressure-guided bone cement injection device 10 in which at least one sensing unit 14 is disposed at any position of the pressure unit 11. Through this design, the user or the control unit 13 can more accurately understand the operating information such as the operating status, environmental status and real-time changes in pressure intensity of the pressure unit 11 from the observation results of the at least one sensing unit 14. What's more, the bone cement delivery status of the push unit 12 can be indirectly obtained through the aforementioned information, and the corresponding pressure intensity adjustment can be made. Compared to other types of bone cement injectors in the prior art, including bone cement injection systems that also have pressure guidance but lack a sensing device, the pressure-guided bone cement injection method provided by the present invention can more accurately grasp the operation process, and the pressure provided by the injection target area affects the effectiveness of bone cement injection and makes corresponding adjustments, making the bone cement injection process smoother and avoiding the high leakage risk caused by inappropriate pressure. At the same time, the sensing and adjustment of pressure intensity are values that indirectly affect bone cement injection, and can still obtain quite fine and subtle changes in injection conditions when adjusting a larger adjustment value. On the other hand, when the sensing position is far away from the actual injection end of the bone cement, the changes in the surrounding environmental parameters can be simpler, and the measured values obtained are more accurate. Therefore, more accurate feedback values can be obtained to adjust the pressure intensity, thereby improving the ease of operation of the injection system.
具體來說，本發明所提供之骨水泥注射方法。其中，由於骨水泥材料於注射的過程中會逐漸凝固，因此無法將壓力感測器設置在骨水泥注射器的內部，於本發明一較佳實施例之中，該感測單元14設計於該推動單元12與該骨水泥導入裝置10之間，如果該骨水泥導入裝置10內的壓力上升，由於阻力增加使推動單元施力上升，造成壓力感測器承受壓力也上升，藉以估測骨水泥注射壓力。此方法可藉由監測初始壓力值、居間壓力值、最大壓力值。透過演算法模組計算與回饋控制之機制，在骨水泥不斷注入與凝固的重複過程中，精準判斷注射目標區域的內壓上升速率與骨水泥飽和程度，良好評估並回饋注射目標區域的骨水泥量與何時該停止注射。上述內容皆可有效的避免因為不適當的施予壓力所造成的高滲漏風險，另一方面，由於骨水泥在抽吸過程中，可能凝固於椎體內或是管路之間，若無法確切得知施於椎體兩端的壓力差，無從確認壓力的上升原因是來自於注射目標區域已填充完成或是因為管路阻塞，因此，將該至少一感測單元14設置於該壓力單元11上，確實能提供不同於現有技術的感測數據，並給予更高的檢測準確度；基於前述之內容，本發明所提供之該至少一個感測裝置14所感測之該至少一環境參數係包含目標部位內之壓力。Specifically, the bone cement injection method provided by the present invention. Since the bone cement material will gradually solidify during the injection process, it is impossible to set the pressure sensor inside the bone cement syringe. In a preferred embodiment of the present invention, the sensing unit 14 is designed between the pushing unit 12 and the bone cement introduction device 10. If the pressure inside the bone cement introduction device 10 increases, the force applied by the pushing unit increases due to the increase in resistance, causing the pressure on the pressure sensor to also increase, thereby estimating the bone cement injection pressure. This method can monitor the initial pressure value, the intermediate pressure value, and the maximum pressure value. Through the algorithm module calculation and feedback control mechanism, during the repeated process of bone cement injection and solidification, the internal pressure rise rate and bone cement saturation level of the injection target area can be accurately judged, and the amount of bone cement in the injection target area and when to stop injection can be well evaluated and fed back. The above contents can effectively avoid the high leakage risk caused by inappropriate pressure. On the other hand, since bone cement may solidify in the vertebral body or between the pipelines during the suction process, if the pressure difference applied to the two ends of the vertebral body cannot be accurately known, it is impossible to confirm whether the reason for the increase in pressure is due to the completion of filling of the injection target area or due to pipeline blockage. Therefore, setting the at least one sensing unit 14 on the pressure unit 11 can indeed provide sensing data different from the existing technology and provide higher detection accuracy. Based on the above contents, the at least one environmental parameter sensed by the at least one sensing device 14 provided by the present invention includes the pressure in the target area.
請參閱本發明之發明圖式第2圖，其係為本發明所提供之演算法控制壓力引導骨水泥注射之方法另一較佳實施例之圖示。當臨床醫師起始治療，可以預先於控制單元13設定可變之壓力初始值，隨後感測單元14進行監測壓力單元11之壓力值。當推動單元12開始灌注骨水泥後，演算法模組131會計算壓力變化速率，在一段量測時間與判斷後演算法會命令壓力單元11加大壓力輸出值，直到居間壓力值提升到最大輸出值，裝置停止注射骨水泥。如第2圖為例，壓力初始壓力值可以設定為400mmHg，當測量到壓力為400mmHg拉不動骨水泥時，加大居間壓力輸出值至500mmHG，壓力輸出提升至500mmHg，以此類推直到提升至最大輸出值，以此實施例為例是680mmHg，演算法判斷停止灌注骨水泥。Please refer to the invention diagram Figure 2 of the present invention, which is a diagram of another preferred embodiment of the algorithm-controlled pressure-guided bone cement injection method provided by the present invention. When the clinician starts treatment, the control unit 13 can set the variable initial pressure value in advance, and then the sensing unit 14 monitors the pressure value of the pressure unit 11. When the push unit 12 starts to inject bone cement, the algorithm module 131 will calculate the pressure change rate. After a period of measurement and judgment, the algorithm will command the pressure unit 11 to increase the pressure output value until the intermediate pressure value is increased to the maximum output value, and the device stops injecting bone cement. As shown in Figure 2, the initial pressure value can be set to 400 mmHg. When it is measured that the pressure is 400 mmHg and cannot pull the bone cement, the intermediate pressure output value is increased to 500 mmHG, and the pressure output is increased to 500 mmHg, and so on until it reaches the maximum output value, which is 680 mmHg in this embodiment. The algorithm determines to stop pouring bone cement.
第3圖描繪控制演算法S101之一詳細實例，演算法模組131例示性包括壓力控制演算法S101。如所論述，壓力控制演算法S101包括監測某些參數(例如壓力變化速率、椎體內骨水泥飽和程度)。該等參數可連續或週期性地監測。壓力控制演算法S101針對預定參數概況檢查所監測參數以確定該等參數個別或組合是否在預定參數概況所設定之範圍內。若所監測參數在預定參數概況所設定範圍內，則可命令之壓力輸出繼續注射骨水泥。若所監測之參數不在預定參數概況所設定之範圍內，則演算法131相應調整命令之壓力輸出或是終止壓力輸出。以下為演算法131可調整/或終止/中斷命令之壓力輸出情況的非詳細清單： (1)所量測壓力變化速率超過預設壓力變化閥值 (2)輸出壓力值超出最大壓力輸出值 (3)壓力變化速率小於預設壓力變化閥值 (4)脊椎椎體內骨水泥趨近飽和範圍FIG. 3 depicts a detailed example of a control algorithm S101, where the algorithm module 131 illustratively includes the pressure control algorithm S101. As discussed, the pressure control algorithm S101 includes monitoring certain parameters (e.g., rate of pressure change, saturation of bone cement in the vertebral body). Such parameters may be monitored continuously or periodically. The pressure control algorithm S101 checks the monitored parameters against a predetermined parameter profile to determine whether the parameters, individually or in combination, are within the range set by the predetermined parameter profile. If the monitored parameters are within the range set by the predetermined parameter profile, the pressure output may be commanded to continue injecting bone cement. If the monitored parameter is not within the range set by the predefined parameter profile, then algorithm 131 will adjust the commanded pressure output accordingly or terminate the pressure output. The following is a non-exhaustive list of situations in which algorithm 131 may adjust/terminate/interrupt the commanded pressure output: (1) The measured pressure change rate exceeds the preset pressure change threshold value (2) The output pressure value exceeds the maximum pressure output value (3) The pressure change rate is less than the preset pressure change threshold value (4) The bone cement in the vertebral body approaches the saturation range
演算法流程圖中之流程區塊：S102於控制單元13設定可變初始壓力輸出值；初始壓力值可自行設定，例如為400mmHg；S104計算椎體內骨水泥趨近飽和範圍；壓力輸出值減去壓力輸出值乘以一參數，其參數可自行設定；S106透過感測單元14監控或讀取壓力單元11之壓力值，S108推動單元12開始灌注骨水泥到椎體內，S110使用差分法或是微分法計算壓力變化速率；S112比較壓力變化速率與壓力變化閥值並且計算骨水泥飽和程度；使用監測到之壓力值除以壓力輸出值計算骨水泥飽和程度；若壓力變化速率小於壓力變化閥值則進入S114，S114命令控制系統13加大壓力輸出值；以此實施例為壓力初始壓力值從400mmHg調大為居間壓力值500mmHg，進入決策區塊S116比對壓力值與骨水泥飽和範圍，若壓力值小於骨水泥飽和範圍，則回到S106重新監測壓力值，隨後重複S102至S116流程，直到可輸出壓力值達到最大值；以此實施例為例680mmHg，當進入決策區塊S116壓力值大於骨水泥飽和範圍，則進入S118演算法命令推動單元12停止注射骨水泥。The flow blocks in the algorithm flow chart are as follows: S102 sets a variable initial pressure output value in the control unit 13; the initial pressure value can be set by oneself, for example, 400 mmHg; S104 calculates the saturation range of the bone cement in the vertebral body; the pressure output value is subtracted from the pressure output value multiplied by a parameter, the parameter of which can be set by oneself; S106 calculates the pressure output value through the sensing unit 1 4. Monitor or read the pressure value of the pressure unit 11. S108 pushes the unit 12 to start pouring bone cement into the vertebral body. S110 uses the differential method or the differential method to calculate the pressure change rate. S112 compares the pressure change rate with the pressure change valve value and calculates the bone cement saturation. The monitored pressure value is divided by the pressure output value to calculate the bone cement saturation. degree; if the pressure change rate is less than the pressure change valve value, enter S114, S114 commands the control system 13 to increase the pressure output value; in this embodiment, the initial pressure value is adjusted from 400mmHg to the intermediate pressure value of 500mmHg, enter the decision block S116 to compare the pressure value with the bone cement saturation range, if the pressure value is less than the bone cement saturation range, return to S106 to re-monitor the pressure value, and then repeat the process from S102 to S116 until the output pressure value reaches the maximum value; in this embodiment, for example 680mmHg, when entering the decision block S116, the pressure value is greater than the bone cement saturation range, then enter S118 algorithm command push unit 12 to stop injecting bone cement.
舉例而言，當壓力在注射過程中因為腔體被填滿而不斷上升達到注射量測閥值時，表示骨水泥於操作位置的填充已執行完畢，又或者，當操作環境有所堵塞不適合進行骨水泥的注射時，將使壓力單元連接上時量測到很快速的壓力變化值，而判定為不適合進行操作的狀態，因此，藉由前述設計，可獲得一個不僅於操作過程中回饋即時迅速，更在系統如何選擇開始操作及操作完成上具有良好的回饋機制的骨水泥注射系統。For example, when the pressure continues to rise during the injection process because the cavity is filled and reaches the injection measurement valve value, it means that the filling of bone cement at the operating position has been completed. Or, when the operating environment is blocked and is not suitable for bone cement injection, the pressure unit will measure a very rapid pressure change when it is connected, and it will be determined as a state that is not suitable for operation. Therefore, through the above design, a bone cement injection system can be obtained that not only provides instant and rapid feedback during the operation, but also has a good feedback mechanism on how the system chooses to start and complete the operation.
基於前述之內容，本發明所提供之該至少一環境參數係包含壓力導入裝置內之壓力、壓力單元內之壓力或目標部位內之壓力。Based on the above content, the at least one environmental parameter provided by the present invention includes the pressure in the pressure introduction device, the pressure in the pressure unit or the pressure in the target area.
綜上所述，本發明確實提供一種演算法控制 負壓力引導骨水泥注射之系統，其可在骨水泥注射的過程當中即時的觀察到操作系統中的環境參數，包含該壓力引導骨水泥注射裝置作用位置之壓力，並回傳至該壓力引導骨水泥灌注系統之控制裝置當中，針對脊椎椎體內骨水泥飽和程度差異改變注射條件，克服現有技術下進行骨水泥注射所具有之堵塞及外漏情況，並有效提升骨水泥注射之注射效率及安全性。In summary, the present invention does provide an algorithm-controlled negative pressure-guided bone cement injection system, which can observe the environmental parameters in the operating system in real time during the bone cement injection process, including the pressure at the action position of the pressure-guided bone cement injection device, and transmit it back to the control device of the pressure-guided bone cement perfusion system, and change the injection conditions according to the difference in the saturation of bone cement in the vertebral body, thereby overcoming the blockage and leakage of bone cement injection under the existing technology, and effectively improving the injection efficiency and safety of bone cement injection.
以下，以具體實施之範例作為此發明之組織技術內容、特徵及成果之闡述之用，並可據以實施，但本發明之保護範圍並不以此為限。The following examples of specific implementations are used to illustrate the organizational technical content, features, and results of this invention, and can be implemented accordingly, but the scope of protection of this invention is not limited to them.
實施例1，壓力引導之骨水泥注射裝置之引用：本實施例的壓力引導骨水泥注射方法，需使用一壓力引導之骨水泥注射裝置，該裝置提供一具有壓力幫浦作為壓力引導之來源，且該壓力幫浦係與另一端設置有導入開口的針管進行連接，藉由該針管將壓力導入目標部位；另一方面，骨水泥注射幫浦則是具有一調節閥，用以控制骨水泥注射幫浦的正壓壓力，而該骨水泥注射幫浦同樣是與另一端設置有導入開口的針管進行連接，可透過骨水泥注射幫浦所給予的壓力將骨水泥導入目標部位。Embodiment 1, reference to a pressure-guided bone cement injection device: The pressure-guided bone cement injection method of this embodiment requires the use of a pressure-guided bone cement injection device, which provides a pressure pump as a source of pressure guidance, and the pressure pump is connected to a syringe with an introduction opening at the other end, and the pressure is introduced into the target site through the syringe; on the other hand, the bone cement injection pump has an adjusting valve for controlling the positive pressure of the bone cement injection pump, and the bone cement injection pump is also connected to a syringe with an introduction opening at the other end, and the bone cement can be introduced into the target site through the pressure provided by the bone cement injection pump.
感測裝置方面，壓力引導裝置置有一壓力感測器，用以感測目標部位的壓力值，評估目標部位的阻力狀態以調整壓力的強度或骨水泥的注射速率。In terms of the sensing device, the pressure guidance device is equipped with a pressure sensor to sense the pressure value of the target site and evaluate the resistance state of the target site to adjust the pressure intensity or the injection rate of bone cement.
另外，本實施例的控制單元，其內含一演算法模組，可針對目標部位、及骨水泥注射裝置的壓力變化訊號進行記錄並分析處理，並綜合相關數據對骨水泥注射模式進行評估，並進行壓力強度、骨水泥注射的調整、下達停止骨水泥灌注指令或提示。In addition, the control unit of the present embodiment includes an algorithm module that can record and analyze the pressure change signals of the target site and the bone cement injection device, and evaluate the bone cement injection mode based on the relevant data, and adjust the pressure intensity and bone cement injection, and issue instructions or prompts to stop bone cement perfusion.
實施例2，壓力引導骨水泥注射之方法操作：當實施例1所提供之壓力引導骨水泥注射裝置開啟前，操作者可決定壓力單元初始輸出壓力值，決定初始壓力輸出值後，控制系統計算骨水泥趨近飽和範圍，壓力單元中的壓力幫浦開始運轉，此時該壓力感測器可測得一壓力值並回傳至演算法計算壓力變化速率，並與壓力變化閥值進行比較，若感測獲得之壓力變化超出閥值，則送出控制訊號，停止骨水泥灌注，若感測獲得之壓力變化小於閥值，加大壓力輸出值，直到到達最大壓力輸出值或是趨近骨水泥飽和範圍，送出控制訊號，停止骨水泥灌注。Example 2, method of pressure-guided bone cement injection: Before the pressure-guided bone cement injection device provided in Example 1 is turned on, the operator can determine the initial output pressure value of the pressure unit. After determining the initial pressure output value, the control system calculates that the bone cement is close to the saturation range, and the pressure pump in the pressure unit starts to operate. At this time, the pressure sensor can measure a pressure value and The pressure change rate is calculated and compared with the pressure change valve value. If the pressure change sensed exceeds the valve value, a control signal is sent to stop bone cement perfusion. If the pressure change sensed is less than the valve value, the pressure output value is increased until it reaches the maximum pressure output value or approaches the bone cement saturation range, and a control signal is sent to stop bone cement perfusion.
於此一實施例當中，對壓力輸出裝置之指令將其初始壓力輸出值設置為400mmHg，當椎體內400mmHg拉不動骨水泥時，居間壓力值提升至500mmHG，以此類推逐漸加大壓力輸出值，直到提升至最大輸出值，以此實施例為例是680mmHg，則演算法判斷停止灌注，命令裝置停止灌注骨水泥。In this embodiment, the command for the pressure output device sets its initial pressure output value to 400 mmHg. When 400 mmHg in the vertebral body cannot pull the bone cement, the intermediate pressure value is increased to 500 mmHG, and the pressure output value is gradually increased in this way until it reaches the maximum output value, which is 680 mmHg in this embodiment. The algorithm then determines to stop perfusion and instructs the device to stop perfusing bone cement.
於此一實施例當中，經過一段時間，當測得目標內壓力變化上升時，則將會逐漸提高壓力馬達的運轉轉速以提高提供的壓力，以此實施例為例：最大輸出值為680mmHg，如第4、5圖所示，基於前述之原則，本發明所提供之壓力引導骨水泥注射方法可透過壓力的引導，使骨水泥被導入患部的進程將會加快，同時骨水泥持續呈現流動的狀態而不至於停滯，減少骨水泥在導入過程中產生凝固的可能性。藉由壓力的引導使大部分的骨水泥被帶離脊椎椎體內，只留下些微骨水泥在椎體內壁上，如此步驟使骨水泥慢慢充填滿脊椎椎體內。In this embodiment, after a period of time, when the target internal pressure changes and increases, the rotation speed of the pressure motor will be gradually increased to increase the pressure provided. Taking this embodiment as an example: the maximum output value is 680 mmHg, as shown in Figures 4 and 5. Based on the above principles, the pressure-guided bone cement injection method provided by the present invention can guide the pressure to accelerate the process of bone cement being introduced into the affected part. At the same time, the bone cement continues to flow without stagnating, reducing the possibility of bone cement solidification during the introduction process. Most of the bone cement is taken away from the spinal vertebral body by the guidance of pressure, leaving only a small amount of bone cement on the inner wall of the vertebral body. In this way, the bone cement slowly fills the spinal vertebral body.
實施例3，本演算法控制壓力引導骨水泥注射系統之骨水泥注射效率評估：椎體成形術或球囊錐體成形術當中，骨水泥注射成效的評價判斷原則如發明圖示第6圖所示，其係為骨水泥注射情況的X光影像照片，如第6圖所示，被認為注射情形「極佳」的骨水泥分布情況，在開始注射骨水泥後，大量的骨水泥於流動狀態被壓力吸出，只剩少量骨水泥凝固在脊椎椎體內壁上。Embodiment 3, the present algorithm controls the bone cement injection efficiency evaluation of the pressure-guided bone cement injection system: During vertebroplasty or balloon vertebroplasty, the evaluation and judgment principle of the bone cement injection effectiveness is shown in FIG6 of the invention illustration, which is an X-ray image of the bone cement injection situation. As shown in FIG6, the bone cement distribution situation that is considered to be an "excellent" injection situation is that after the bone cement injection begins, a large amount of bone cement is sucked out by pressure in a flowing state, leaving only a small amount of bone cement solidified on the inner wall of the vertebral body.
惟以上所述者，僅為本創作之較佳實施例而已，並非用來限定本創作實施之範圍，舉凡依本創作申請專利範圍所述之形狀、構造、特徵及精神所為之均等變化與修飾，均應包括於本創作之申請專利範圍內。However, what is described above is only the best embodiment of this creation and is not used to limit the scope of implementation of this creation. For example, all equivalent changes and modifications made based on the shape, structure, characteristics and spirit described in the patent application scope of this creation should be included in the patent application scope of this creation.
10:骨水泥注射裝置 11:壓力單元 12:推動單元 13:控制單元 14:感測單元 101:控制演算法 131:演算法模組10: Bone cement injection device11: Pressure unit12: Push unit13: Control unit14: Sensing unit101: Control algorithm131: Algorithm module
第1圖：其係為本發明之壓力引導骨水泥注射裝置之一較佳實施例之系統方塊圖； 第2圖：其係為本發明之壓力引導骨水泥注射方法之一較佳實施例之系統流程圖； 第3圖：其係為本發明之壓力引導骨水泥注射方法之一較佳實施例之圖示； 第4圖：其係為本發明之壓力引導骨水泥注射方法之一較佳實施例之圖示； 第5圖：其係為本發明之壓力引導骨水泥注射方法之一較佳實施例之圖示； 第6圖：其係為本發明之壓力引導骨水泥注射系統之一較佳實施例之圖示。Figure 1: It is a system block diagram of a better embodiment of the pressure-guided bone cement injection device of the present invention; Figure 2: It is a system flow chart of a better embodiment of the pressure-guided bone cement injection method of the present invention; Figure 3: It is a diagram of a better embodiment of the pressure-guided bone cement injection method of the present invention; Figure 4: It is a diagram of a better embodiment of the pressure-guided bone cement injection method of the present invention; Figure 5: It is a diagram of a better embodiment of the pressure-guided bone cement injection method of the present invention; Figure 6: It is a diagram of a better embodiment of the pressure-guided bone cement injection system of the present invention.
無without
S101:方法S101: Methods
S102~S118:步驟S102~S118: Steps
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| TW111128848ATWI860537B (en) | 2021-07-30 | 2022-08-01 | Pressure guided bone cement injection method and instrument |
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| EP (1) | EP4378406A4 (en) |
| JP (1) | JP2024527118A (en) |
| CN (1) | CN117979914A (en) |
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| JP2024527118A (en) | 2024-07-19 |
| EP4378406A1 (en) | 2024-06-05 |
| US20240335220A1 (en) | 2024-10-10 |
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